新止咳合剂稳定性的初步研究  

Preliminary Study on stability of Xin Zhike Mixture

作　　者：杨晓峰 李惠英[1] 李聃 代泽友 李瑞芸 秦利芬[1] YANG Xiaofeng;LI Huiyin;LI Dan;DAI Zeyou;LI Ruiyun;QIN Lifen(Kunming children's Hospital,Kunming 650000,China)

机构地区：[1]昆明市儿童医院,云南昆明650000

出　　处：《云南化工》2025年第4期34-38,共5页Yunnan Chemical Technology

基　　金：昆明市科技计划项目(编号:2024-1-NS-21)。

摘　　要：考察医院制剂新止咳合剂的稳定性和有效期。根据《中国药典》2020版第四部“原料药物与制剂稳定性试验指导原则”对制剂进行影响因素试验、加速试验和长期试验,按新止咳合剂质量标准中检验项目考察其性状、鉴别、装量、相对密度、pH值和微生物限度。利用Minitab分析,并估算制剂有效期。结果表明,在强光试验条件下(照度为4500lx±500lx),制剂性状改变,颜色变深;在长期试验条件下(温度25℃±2℃、相对湿度60%±10%),第36个月制剂颜色变深,其余各项指标均符合规定。新止咳合剂稳定性良好,在常温、密封、避光条件下能稳定储存,可考虑制剂有效期定为24个月。[Objective]To investigate the stability and validity of Xin zhike He Ji.[Methods]The stability test of Xin Zhike Mixture was carried out in accordance with the requirements of the stability test method of the preparation in the general rule of the fourth part of the Chinese Pharmacopoeia(2020 edition),The influencing factors test,accelerated test and long-term test were carried out in the preparation,and the characters,identification,loading,relative density,pH value and microbial limit were examined according to the quality standard of the new cough mixture.Minitab analysis was used to estimate the period of validity of the preparation.[Results]The color of the preparation became darker under the condition of strong light test(the illuminance was 4500 lx±500 lx).Under the condition of long-term test(temperature 25℃±2℃,relative humidity 60%±10%),the color of the preparation became darker after 36 months,and the other indexes were in accordance with the regulations.[Conclusion]Xin Zhi ke Mixture is stable and can be stored stably under the normal temperature,seal up,dark area.The term of validity can be set at 24 months.

关 键 词：新止咳合剂 稳定性试验 医院制剂 有效期 储存 

分 类 号：R283[医药卫生—中药学]